Front page, June 7, 2005
J&J's New Device
For Spine Surgery
Artificial Disk Aims to Help
Body's Natural Movement;
Some See Risk if It Slips
'Big Money Riding on This'
L. RUNDLE and SCOTT HENSLEY
Staff Reporters of THE WALL STREET JOURNAL
June 7, 2005; Page A1
like an excellent answer for persistent back pain:
an artificial disk, placed between the bones of the
spine, that helps the body move naturally. After
decades of research by doctors, Johnson & Johnson
became the first to market an artificial disk in
the U.S. last October, and surgeons are flocking
to a J&J training center in Cincinnati to learn
how to implant it.
Now a vigorous
debate has emerged among doctors about the durability
of the J&J device and its effectiveness compared
with older "fusion" surgery, in which the
bones of the spine are fused together. Some surgeons
are predicting that a wave of patients will suffer
complications over the next 10 to 15 years and need
to have the device, called Charité, removed.
That's particularly worrisome because the surgery
to take it out can be dangerous -- more so, they
say, than the repairs when fusion surgery goes wrong.
says malfunctions are rare. About 5% of Charité patients
need a new operation to fix problems, in line with
older surgeries, says Richard Toselli, vice president
for research and development at J&J's DePuy Spine
subsidiary. He says in most cases repair surgery
doesn't involve big risks.
proper patient selection and good surgical technique,
the patients are generally very happy," Dr.
Toselli says. "We're confident this is a definite
improvement over fusion."
pain has long stymied doctors. Many cases seem to
stem from problems with the disks, which are like
spongy shock absorbers between the bones of the spine.
Thanks to the disks, people can bend and twist their
backs in many directions. But sometimes disks slip
out of position, bumping into nerves and causing
pain. They can also degenerate with age or from the
stress of repetitive motions.
exercise or painkillers don't relieve the pain, the
traditional solution has been fusion surgery. Surgeons
extract the troublesome disk or disks and fuse spinal
bones together -- aiming to reduce pain at the expense
of some flexibility. Low-back fusion surgery is performed
nearly 200,000 times annually in the U.S.
knee-fusion surgery has mostly been phased out in
favor of knee replacements that allow people to walk
almost normally, the artificial disks are designed
to keep the spine moving in its natural way. The
Charité -- a plastic core sandwiched between
metal plates -- is implanted between the bones after
the patient's own disk is removed. About 2,500 people
have received the Charité disk since it was
approved last year by the Food and Drug Administration.
the market for artificial disks, including Charité and
others still being studied, could approach $1.7 billion
a year, according to a recent estimate by J.P. Morgan.
Charité's list price is $11,500. Spine surgery
also brings in big money for hospitals: A single
operation, whether for an artificial disk or spinal
fusion, can cost $50,000 or more including all fees.
of Indianapolis sought relief from back pain with
everything from Pilates exercises to cortisone shots,
to no avail. So when a surgeon told her that she
was an ideal candidate for an artificial disk, she
decided to go under the knife in January.
went smoothly, her recovery was swift and her pain
almost disappeared. But one morning a month later,
she woke up with a hugely swollen leg. Tests showed
that her Charité had slipped from its place
between bones of the spine. She needed emergency
surgery to remove the disk, which had become intertwined
with blood vessels.
am lucky to be alive now," says Ms. Whittaker,
a 52-year-old golfing enthusiast. During the nine-hour
removal surgery, she lost a lot of blood. "I
almost died on the table, twice," she says.
fusion fails, doctors can generally access the problematic
spot from the patient's back, avoiding damage to
vital organs. But to remove an artificial disk, surgeons
must go through a patient's abdomen. Because scar
tissue sets in after the initial surgery, it's more
difficult the second time to move the major veins
and arteries that block access to the spine. That
is why patients such as Ms. Whittaker are at risk
of severe bleeding.
Dr. Toselli says that of 11 patients who needed repair
surgery for Charité in a key clinical trial
only two had to have the disk removed. The others
were able to get by with supplemental fusion surgery
and didn't need to have their abdomens opened a second
time. Dr. Toselli says fixing fusion surgery may
also occasionally require a second abdominal cut.
an Indianapolis surgeon who performed Ms. Whittaker's
disk replacement and emergency surgery, says he still
thinks the Charité may be right for some people
but patients need to know there are unanswered questions
about it. One of those questions is why Ms. Whittaker's
disk slipped out of place. "We've sent films
to surgeons all over the country," says Dr.
Riina, who has instructed other doctors about the
device. "No one has been able to give a reason
for what happened." Ms. Whittaker hasn't sued
anyone over the problems. J&J declined to comment
on her case, citing incomplete information about
critics, including some insurance companies that
are refusing to cover the procedure, focus on the
key trial of 304 people that J&J used to win
FDA approval of the device. They say the two-year
trial was too short to prove that the artificial
disk can sit in the spine indefinitely without falling
out of place or causing other problems. What's more,
Charité was compared in the trial with a then-standard
version of fusion surgery that is now outdated and
it worked no better in relieving pain after two years.
forms of fusion surgery, doctors chop out a chunk
of the pelvic bone to use in fusing the spinal bones.
Today, surgeons often use a biologic material called
bone morphogenetic protein to stimulate bones to
approval of Charité "puts the American
people potentially at great risk for receiving operations
that could fail at a high rate and result in untreatable
pain and disability," says Charles D. Rosen,
a surgeon at the University of California at Irvine's
spine center. He says he has spent considerable time
reviewing European studies, FDA transcripts and other
data on the Charité's safety. Dr. Rosen wrote
a letter to the FDA last month demanding that the
agency rescind its approval.
An FDA spokeswoman
said the potential risks of the Charité, including
the possibility of it getting dislodged, were considered
during the review process. She said all back procedures
have risks and benefits, and the agency is monitoring
the academic debate.
are aggressively promoting disk replacement on their
Web sites and in articles for specialist journals
and the popular press. The promotions describe the
new treatment with terms such as "revolutionary" and
say it's suited to young, otherwise-healthy people
who want to stay active. Many depict spinal fusion
as problematic because it allegedly puts strain on
the body's surviving natural disks. Whether that
is so has yet to be proven, and Johnson & Johnson
hasn't shown that Charité avoids this risk.
Charité's critics predict that future artificial
disks will be better. Medtronic Inc. of Minneapolis
and Synthes Inc. of Switzerland both have artificial
disks in U.S. clinical testing. John Peloza, a spine
surgeon in Dallas, calls the Charité "a
nightmare to fix" but thinks other devices using
different materials might survive longer in the body. "I'm
not trying to wreck spinal arthroplasty," he
says, referring to artificial disks. "I'm trying
to save it from a big black brush when [the Charité]
At a packed
Canadian meeting of spine specialists in January,
Dr. Peloza accused Fred Geisler, a Chicago surgeon
and J&J consultant, of hyping the Charité by
suggesting in a presentation that it is superior
to fusion surgery. Dr. Geisler says that is what
his analysis of the clinical-trial data shows using
multiple statistical tests, although J&J's own
marketing describes Charité as an alternative
to fusion rather than as a superior procedure.
is aligned with Medtronic, so he thinks the Medtronic
disk is better," says Dr. Geisler. "There
is big money riding on this. Where there is big money,
there are no disinterested people." Dr. Peloza
confirms he is a Medtronic consultant, but says that
doesn't affect his view of the Charité.
of implanting artificial disks has been around for
more than 30 years. The original version of the Charité was
developed by orthopedic surgeon Karin Büttner-Janz,
a former East German Olympic gymnast, and Kurt Schnellnack.
It was named after the Charité hospital in
Berlin where it was introduced in the 1980s. There
are many other designs for artificial disks including
some that would be implanted in the neck. Only Charité,
which is designed for the low back, is FDA-approved.
began to take off when big global medical-device
companies began buying up small disk makers. In 2003
J&J's DePuy unit acquired Link Spine Group, owner
of the Charité.
Charité was approved, Americans suffering
from back pain journeyed to spine centers in France,
Germany and Australia to get artificial disks. Mark
Mintzer, a 48-year-old former computer consultant,
said his back pain forced him to live like a "shut-in" for
two years before he went to the Alpha Klinik in Munich
in 2002. He mortgaged his house in Fountain Valley,
Calif., to cover the $22,000 cost of disk replacement
surgery plus about $6,000 in travel expenses for
himself and his wife.
after surgery, he was playing tennis. Later he resumed
scuba-diving and flying planes. Today, he runs a
small business out of his home to link prospective
patients to U.S. and European spine surgeons.
of Los Angeles has performed nearly 200 Charité surgeries
and says patients "do consistently better than
patients of any other surgery we do." He says
he receives royalty payments from J&J in connection
with his work on Charité but they don't influence
his professional judgment. Dr. Regan's patients were
treated at Cedars-Sinai Medical Center in Los Angeles,
which promotes artificial disk replacement in radio
critic of artificial disks, André van Ooij
of University Hospital Maastricht in the Netherlands,
warns against judging from early results. "Most
patients will be happy for the first years, but the
big problem will arise in later years," says
Dr. van Ooij. "I am very negative about disk
prostheses in general and the Charité disk
Ooij has tallied 58 cases of Charité complications,
including 27 that he reported in the Journal of Spinal
Disorders & Techniques in August 2003. In many
cases surgeons did a bad job inserting the device
or chose the wrong size for the patient. More worrisome:
Some problems occurred even when surgeons did everything
right. Dr. van Ooij believes that artificial disks,
rather than allowing the body to move naturally,
instead promote "bad motion" in the spine.
Ooij sent eight devices that had been surgically
removed to Steven Kurtz, principal engineer at Exponent
Inc., a scientific consulting firm in Menlo Park,
Calif. Dr. Kurtz concluded that the disks wear out
in a manner similar to artificial hips and knees
that generally last up to about 10 years. Such longevity
is acceptable in elderly patients, the typical recipients
of artificial hips, but may be a problem for the
younger patients who often have surgery for back
pain. Dr. Kurtz, who has consulted for Medtronic
and other medical-device makers, says many younger
patients who are getting artificial disks may need
a life-threatening operation to remove a worn disk
in 10 years or less.
Johnson & Johnson
disagrees. It says its tests showed Charité's
plastic core can withstand 80 years of wear and tear,
far more than the typical hip implant. The company
points to the results of a leading French spine surgeon,
Jean-Philippe Lemaire, who has reported that 90 of
the 100 patients he followed for 10 years had good
or excellent results. Only two had complications
involving the disk itself.
of the Charité agree that inadequately trained
doctors could botch implantation of the disk. At
a training center and surgical laboratory in Cincinnati,
J&J has given intensive instruction to more than
2,000 surgeons. By the fall, that number is expected
to grow to 3,000.
At a recent
training session, 24 doctors split up into two-man
teams to practice implanting disks in calf spines.
Each table had a TV screen so the doctors could watch
and imitate the instructor as he operated on another
calf spine. At one operating table, Dr. Toselli,
the J&J spine-research chief, cut through ligaments
covering the front of the spine to reveal the calf's
glistening, whitish disk. He removed it methodically
with long-handled gouges. After determining the proper
size and angle for the implant, Dr. Toselli pried
the spine bones apart with a pair of forceps and
drove the implant into place with a steel hammer.
doctors also received instruction on how to get paid
for the surgery, including tips on appealing thumbs-down
verdicts from insurers. The instructors included
J&J employees and veteran surgeons who tested
Charité in clinical trials.
question period, doctors peppered the lecturers with
questions about the durability of the disk and the
kind of patients who could be treated. Some wondered
whether fusion surgery could offer superior results. "Physicians,
in general, are suspicious of new technology, and,
as a company, we want them to be," says Dr.
Toselli. He said he's confident doctors will appreciate
Charité's merits once they try it.
say they're worried they will lose business if they
don't offer the Charité option to patients. "There's
a feeling that it isn't adequately proven, but there's
anxiety about being left behind," says Bernard
Guiot, director of the spine program at the University
of South Florida. Dr. Guiot went to the Cincinnati
center in April to get credentialed, and praises
J&J for its research and commitment to training.
He says he might use Charité in some patients
but hasn't done so yet.
have taken a mixed view of the device. Kaiser Permanente,
the California-based health maintenance organization,
endorsed the Charité last November after requests
by its doctors but the Blue Cross and Blue Shield
Association concluded there isn't enough evidence
that the device works. Most of the nation's 40 independently
owned Blue Cross and Blue Shield plans are following
is Horizon Blue Cross Blue Shield of New Jersey.
It decided the Charité is right for some patients
and doesn't cost much more than spinal fusion, says
senior medical director Stanley Harris. He puts the
cost of the procedure, including doctor and hospital
fees, at $67,000 per patient. J&J says a more
typical figure is $35,000 to $45,000.